Binocular Vision in Monocular Pseudophakia (BVMP)

This study is currently recruiting participants. (see Contacts and Locations)
Verified June 2013 by University of Oxford
Sponsor:
Collaborator:
Oxford University Hospitals NHS Trust
Information provided by (Responsible Party):
University of Oxford
ClinicalTrials.gov Identifier:
NCT01872000
First received: May 1, 2013
Last updated: June 4, 2013
Last verified: June 2013
  Purpose

Following cataract surgery, an intraocular lens (IOL) is implanted in the eye. The majority of people develop an operable cataract when they are over the age of 50. Occasionally people under 50 years develop a cataract requiring an operation. The visual demands in this age group are very different due to both physiological and lifestyle factors. Traditionally IOLs are focussed for distance vision and additional spectacles are worn for near vision. Under the age of 45 years we have the ability to naturally change the focus of our eyes and do not require additional reading glasses. This is known as accommodation. By removing the cataractous lens and replacing it with an IOL with a fixed single focus, both eyes work together for distance vision but only the unoperated eye is able to change focus for different working distances. This study aims to establish whether a multifocal IOL implanted in one eye is able to complement the accommodation in the other eye so the 2 eyes work more effectively together. This may enhance depth perception and improve the quality of vision. Depth perception is important for more comfortable vision on the computer screen, when reading and for jobs that require good depth perception.


Condition Intervention
Cataract
Procedure: Cataract surgery

Study Type: Interventional
Study Design: Allocation: Randomized
Endpoint Classification: Efficacy Study
Intervention Model: Parallel Assignment
Masking: Double Blind (Subject, Investigator, Outcomes Assessor)
Primary Purpose: Treatment
Official Title: A Prospective Randomised Controlled Trial to Assess Improved Binocular Visual Function in Young Patients Undergoing Monocular Cataract Surgery With a Bifocal Intraocular Lens.

Resource links provided by NLM:


Further study details as provided by University of Oxford:

Primary Outcome Measures:
  • Extent of binocular vision at near working distance following IOL implantation. [ Time Frame: 3-6 months ] [ Designated as safety issue: No ]

Secondary Outcome Measures:
  • Change in visual acuity and subjective visual comfort at distance, intermediate and near working distances following IOL implantation. [ Time Frame: 3-6 months ] [ Designated as safety issue: No ]
    Visual acuity at different distances will be presented in combination as they are linked.


Estimated Enrollment: 40
Study Start Date: April 2013
Estimated Study Completion Date: April 2015
Estimated Primary Completion Date: April 2015 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Experimental: Multifocal IOL
IOL inserted following cataract surgery
Procedure: Cataract surgery
Other Name: Phacoemulsification and IOL insertion
Active Comparator: Standard IOL
IOL inserted following cataract surgery
Procedure: Cataract surgery
Other Name: Phacoemulsification and IOL insertion

  Eligibility

Ages Eligible for Study:   18 Years to 45 Years
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
Criteria

Inclusion Criteria:

  • Participant is willing and able to give informed consent for participation in the study.
  • Male or female, aged 18 - 45.
  • Cataract operation required in one eye only, either due to the presence of cataract affecting visual function, or in combination with surgery which is likely to cause visually significant cataract.
  • Expected visual improvement in operable eye of at least 6/12.
  • Fellow eye with a VA of at least 6/9.
  • Astigmatism of 1.0D or less.
  • Target of emmetropia in the operated eye.
  • Intact posterior capsule with planned implantation into the capsular bag.
  • IOL power required 10 - 30D.

Exclusion Criteria:

  • Pre-existing amblyopia or squint.
  • Significant diabetic retinopathy.
  • Macular off retinal detachment with metamorphopsia or poor visual prognosis.
  • Other macula or ophthalmic pathology affecting macula function resulting in poor visual prognosis.
  • Pregnancy, lactating or planned pregnancy during the study period.
  Contacts and Locations
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT01872000

Contacts
Contact: Jasleen K Jolly, MSc enquiries@eye.ox.ac.uk

Locations
United Kingdom
Oxford University Hospitals NHS Trust Recruiting
Oxford, Oxfordshire, United Kingdom, OX3 9DU
Contact: Jasleen K Jolly, MSc       enquiries@eye.ox.ac.uk   
Principal Investigator: Robert E MacLaren, MB ChB DPhil         
Sub-Investigator: Jasleen K Jolly, MSc         
Sub-Investigator: C K Patel, MBBS         
Sub-Investigator: Paul Rosen, MB ChB         
Sponsors and Collaborators
University of Oxford
Oxford University Hospitals NHS Trust
Investigators
Principal Investigator: Robert E MacLaren, DPhil University of Oxford
  More Information

Additional Information:
No publications provided

Responsible Party: University of Oxford
ClinicalTrials.gov Identifier: NCT01872000     History of Changes
Other Study ID Numbers: BVMP2013
Study First Received: May 1, 2013
Last Updated: June 4, 2013
Health Authority: United Kingdom: National Health Service
United Kingdom: National Institute for Health Research

Keywords provided by University of Oxford:
Intraocular lens
Phacoemulsification

Additional relevant MeSH terms:
Cataract
Lens Diseases
Eye Diseases

ClinicalTrials.gov processed this record on July 23, 2014